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Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04336410
Recruitment Status : Completed
First Posted : April 7, 2020
Last Update Posted : April 15, 2022
Sponsor:
Collaborator:
Coalition for Epidemic Preparedness Innovations
Information provided by (Responsible Party):
Inovio Pharmaceuticals

Study Description
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Brief Summary:
This is an open-label trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device in healthy adult volunteers.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Drug: INO-4800 Device: CELLECTRA® 2000 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers
Actual Study Start Date : April 3, 2020
Actual Primary Completion Date : February 10, 2022
Actual Study Completion Date : February 10, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1: INO-4800
Participants will receive one ID injection of 1.0 milligram (mg) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.
 Drug: INO-4800
INO-4800 will be administered ID on Day 0, Week 4 and at the optional Booster Dose Visit.

Device: CELLECTRA® 2000
EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0, Week 4 and at the optional Booster Dose Visit.
Experimental: Group 2: INO-4800
Participants will receive two ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.
 Drug: INO-4800
INO-4800 will be administered ID on Day 0, Week 4 and at the optional Booster Dose Visit.

Device: CELLECTRA® 2000
EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0, Week 4 and at the optional Booster Dose Visit.
Experimental: Group 3: INO-4800
Participants will receive one ID injection of 0.5 mg of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.
 Drug: INO-4800
INO-4800 will be administered ID on Day 0, Week 4 and at the optional Booster Dose Visit.

Device: CELLECTRA® 2000
EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0, Week 4 and at the optional Booster Dose Visit.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose) ]
  2. Percentage of Participants with Administration (Injection) Site Reactions [ Time Frame: Day 0 up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose) ]
  3. Percentage of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose) ]
  4. Change from Baseline in SARS-CoV-2 Spike Glycoprotein Antigen-Specific Binding Antibody Titers [ Time Frame: Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose) ]
  5. Change from Baseline in Antigen-Specific Cellular Immune Response [ Time Frame: Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at screening.
  • Able and willing to comply with all study procedures.
  • Screening laboratory results within normal limits or deemed not clinically significant by the Investigator.
  • Body Mass Index of 18-30 kg/m^2, inclusive, at screening.
  • Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody at screening.
  • Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome).
  • Use of medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until 3 months following last dose, be post-menopausal, be surgically sterile or have a partner who is sterile.

Exclusion Criteria:

  • Pregnant or breastfeeding or intending to become pregnant or father children within the projected duration of the trial from screening until 3 months following last dose.
  • Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0.
  • Previous exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or receipt of an investigational product for the prevention or treatment of COVID-19, middle east respiratory syndrome (MERS), or severe acute respiratory syndrome (SARS).
  • In a current occupation with high risk of exposure to SARS-CoV-2 (e.g., health care workers or emergency response personnel having direct interactions with or providing direct care to patients).

  • Current or history of the following medical conditions:

    • Respiratory diseases
    • Hypersensitivity or severe allergic reactions to vaccines or drugs
    • Diagnosis of diabetes mellitus
    • Hypertension
    • Malignancy within 5 years of screening
    • Cardiovascular diseases

  • Immunosuppression as a result of underlying illness or treatment including:

    • Primary immunodeficiencies
    • Long term use (≥7 days) of oral or parenteral glucocorticoids
    • Current or anticipated use of disease-modifying doses of anti-rheumatic drugs and biologic disease-modifying drugs
    • History of solid organ or bone marrow transplantation
    • Prior history of other clinically significant immunosuppressive or clinically diagnosed autoimmune disease
  • Fewer than two acceptable sites available for intradermal (ID) injection and electroporation (EP) considering the deltoid and anterolateral quadriceps muscles.
  • Reported smoking, vaping, or active drug, alcohol or substance abuse or dependence.
  • Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04336410


Locations
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United States, Kentucky
Central Kentucky Research Associates
Lexington, Kentucky, United States, 40509
United States, Missouri
Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Inovio Pharmaceuticals
Coalition for Epidemic Preparedness Innovations
Investigators
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Study Director: Dr. Ning Jiang, MD PhD Inovio Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04336410    
Other Study ID Numbers: COVID19-001
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Anonymous IPD may be shared following or during the publication of summary data. Archival data may be accessed for up to 10 years following the end of the study.
Access Criteria: Those who request the anonymous IPD must provide a plan of study explaining how the data will be used. Requests may be sent to the Central Contact Person. Requests will be reviewed based on the potential for the planned use of the IPD for advancing scientific knowledge and theory.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Inovio Pharmaceuticals:
DNA vaccine
Electroporation
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Virus Diseases
Infections